MAUDE Adverse Event Report: ST. JUDE MEDICAL, PUERTO RICO INC SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS

Model Number 25AHP-105

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Stenosis (2263)

Event Date 01/16/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated that this 25mm sjm hemodynamic plus series valve was explanted due to prosthetic stenosis.

• Brand Name: SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS
• Manufacturer (Section D): ST. JUDE MEDICAL, PUERTO RICO INC; caguas PR
• Manufacturer Contact: denise johnson, rn ; 177 east county rd b; st paul, MN 55117 ; 6517564470
• MDR Report Key: 3642024
• MDR Text Key: 4282965
• Report Number: 2648612-2014-00008
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/1998
• Device Model Number: 25AHP-105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/1994
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR